BEUDAMED
    Product Code: QVU FDA class 2 21 CFR 866.6095

    High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.

    Pathology

    The High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System is a prescription qualitative in vitro diagnostic system that uses high-throughput DNA sequencing to detect germline mutations across a panel of targeted cancer-related genes in human specimens, intended to aid in the assessment of hereditary cancer predisposition by qualified healthcare professionals in accordance with established clinical guidelines. It is not intended for population screening, prenatal testing, or as a standalone diagnostic tool. Classified as FDA Class 2 under regulation 866.6095, it requires 510(k) clearance in the Pathology specialty. It is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QVU
    Device Class
    FDA class 2
    Regulation Number
    866.6095
    Medical Specialty
    Pathology
    Review Panel
    PA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations in a panel of targeted cancer related genes. It is intended to aid in hereditary cancer predisposition assessment by qualified health care professionals in accordance with professional guidelines. The device is not intended for screening, prenatal testing or as a stand-alone diagnostic test. The device is for prescription use only.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN210011 Invitae Common Hereditary Cancers Panel